Pipeline Programs

Exegi is focused on research and development of microbiome science in a variety of therapeutic areas.

 

Disease State

Primary Endpoint

Sponsor/Collaborator

Trial Design

Estimated Enrollment

HIV

Reduction of systemic inflammation – Change in CD14 (Time Frame: Baseline (week 2 pre-treatment to week 26))

National Institute of Allergy and Infectious Diseases (NIAID) –  AIDS Clinical Trials Group

Double Blind Placebo Controlled

90

HIV

Blood immune activation – Percent of blood immune activation (co-expression of CD38 and HLA-DR) on CD8 T cells at week 24

Canadian HIV Trials Network

Double Blind Placebo Controlled

36

HIV

Blood immune activation -Percent change in blood immune activation (co-expression of CD38 and HLA-DR) on CD8 T cells at week 48

Canadian HIV Trials Network

Double Blind Placebo Controlled

40

Gulf War Illness

Improvement in the Bowel symptom scale (BSS) from baseline,

IBS related symptoms in Gulf War Illness is measured using BSS at 2, 4, 6, 8 weeks

University of Utah

Double Blind Placebo Controlled

80

Autism Spectrum Disorders

Gastrointestinal (GI) Module of the Pediatric Quality of Life Inventory (PedsQL), Change in Aberrant Behavior Checklist, Social Responsiveness Scale, Parent Anxiety Checklist

The Ohio State University –

Autism Treatment Network and Autism Speaks*

Double Blind Placebo Controlled, Crossover

12/60

Autism Spectrum Disorders

Changes in severity level of ASD symptomatology, Delta of scores at Autism Diagnostic Observation Schedule-2

IRCCS Stella Maris Foundation, Ministry of Health Italy,

CNR Institute of Clinical Physiology

Double Blind Placebo Controlled**

100

Cirrhosis plus Spontaneous Bacterial Peritonitis

Changes in bacterial translocation.

Changes in systemic inflammatory response and systemic oxidative damage. 

Changes in cognitive function.

Foundation Research Institute of the Hospital de Sant Pau, Barcelona Spain

Double Blind Placebo Controlled**

30

 

*This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under cooperative agreement UA3 MC11054 – Autism Intervention Research Network on Physical Health. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government. This work is being conducted through the Autism Speaks Autism Treatment Network serving as the Autism Intervention Research Network on Physical Health.

**Clinical product reported as Vivomixx(r). The De Simone Formulation under evaluation in these reported studies is available as Visbiome(tm) in the U.S. and Vivomixx in Europe.

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